Staff Validation Engineer required for a international engineering company.


Essential Duties and Responsibilities may include, but are not limited to, the following:

• Responsible for preparing and executing commissioning, qualification, and validation for new products, processes, equipment and industrial software as well as assisting in maintaining them in a validated state.
• Supports validation activities in a GMP regulated manufacturing environment. The Validation engineers will prepare, review, and execute commissioning, qualification (IQ, OQ, PQ), and validation (PV and CV) documents for products, facilities, processes, software and equipment.
• Supports Project Teams in: GMP Impact Assessments, Instrument Criticality Lists, Critical Components Lists, Requirements Traceability matrices, Design Qualification, Vendor documentation checklists, final handover of documents to Operations.
• Aids in the planning of commissioning, qualification and validation activities and in interfacing with QA, Production Operators, and Engineering
• Ability to handle multiple commissioning, qualification, validation priorities based on the needs of the manufacturing area with guidance from management.

• Bachelor’s degree in Engineering or related field, or equivalent combination of education and work-related experience, required.
• Minimum 3-5 years Qualification (IQ, OQ, PQ) / Validation (PV, CV), GXP experience.
• Demonstrates potential for technical proficiency, engineering creativity, collaboration with others, and independent thought.
• Demonstrated troubleshooting and problem solving skills including the use of designed experiments.
• Ability to handle multiple tasks/projects
• Good influencing and negotiation skills to accomplish the same goals for internal and external stakeholders according to Project and business need.
• Understanding engineering disciplines, work package management and work package control.